Trials / Unknown
UnknownNCT01844635
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- Nagoya University · Academic / Other
- Sex
- All
- Age
- 69 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Thymoglobulin |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2016-05-01
- First posted
- 2013-05-01
- Last updated
- 2016-04-01
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01844635. Inclusion in this directory is not an endorsement.